Evaluation of Synchrony in the Post-operative Patient (SYNCHRONY)
This study has been completed.
Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01771341
First received: June 15, 2012
Last updated: January 21, 2015
Last verified: January 2015
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Purpose
Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.
This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.
| Condition | Intervention |
|---|---|
|
Patient-ventilator Asynchronism |
Device: MAQUET SERVOi ventilator with Edi Catheter Device: MAQUET SERVOi ventilator |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Evaluation of Synchrony in the Post-operative Patient (NAVA vs Pressure Support) |
Further study details as provided by Hospices Civils de Lyon:
Primary Outcome Measures:
- Asynchrony index (AI) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]Number of asynchrony events/total respiratory rate
Secondary Outcome Measures:
- PaO2/FiO2 ratio [ Time Frame: 8 hours ] [ Designated as safety issue: No ]ratio of partial pressure arterial oxygen and fraction of inspired oxygen
| Enrollment: | 29 |
| Study Start Date: | February 2012 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Pressure support |
Device: MAQUET SERVOi ventilator
Pressure Support
Other Name: Pressure Support
|
| Experimental: NAVA |
Device: MAQUET SERVOi ventilator with Edi Catheter
NAVA respiratory modality
Other Name: Neurally Adjusted Ventilatory Assist
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult > 18 yr-old
- abdominal post-operative patient
- able to trigger the ventilator
Exclusion Criteria:
- infant
- pregnancy
- esophageal surgery
- recent esophageal variceal bleeding
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01771341
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771341
Locations
| France | |
| Hospices Civils de Lyon- Centre Hospitalier Lyon Sud | |
| Pierre Bénite, France, 69310 | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Florent WALLET, MD | Hospices Civils de Lyon |
More Information
No publications provided
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT01771341 History of Changes |
| Other Study ID Numbers: | 2010.646 |
| Study First Received: | June 15, 2012 |
| Last Updated: | January 21, 2015 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hospices Civils de Lyon:
|
NAVA post operative |
ClinicalTrials.gov processed this record on March 03, 2015